Ultrasound imaging device in first stage of FDA approval

A local woman who is pregnant and diagnosed with breast cancer is sharing her story in hopes of helping other women.

Amber Edmunds says she is participating in groundbreaking research at Karmonos Cancer Institute. Called SoftVue, the ultrasound imaging device has been in the works for over a decade and is on the cusp of FDA approval.

In the clinical trial stages, SoftVue is a revolutionary machine that uses sound and water to create 3D ultrasound images of the whole breast. What's pioneering about the machine is that it doesn't involve the discomfort of compression or radiation like a mammogram.

"You feel at ease, you feel better about yourself, you're not uncomfortable," said Edmunds.

The co-inventors are conducting their world-renowned research in Detroit at Karmonos Cancer Institute.

"Having engineering and physics and physicians listen to one another created a real opportunity that isn't seen very often around the world," said Dr. Peter Littrup, co-inventor of SoftVue.

With over a decade of research so far, it's an opportunity co-invented by Dr. Peter Littrup and Dr. Ned Duric at Karmonos Cancer Institute.

"This would be a complete paradigm shift in what we're normally looking at with breast imaging," said Dr. Littrup.

This research was possible in small part thanks to Edmunds.

"I really got involved when my wife came home after her first mammogram and said if you're inventing stuff, you gotta do something about this process."

With SoftVue, the patient lies down on a table over a round opening much like an ice fishing hole. With a camera in the bottom, it fills with warm water where one at a time, the patient's breast is scanned.

"The information that we get from how that sound interacts with the breast tissue tells us what's inside the breast," said Dr. Duric.

The process is much like a CAT Scan or an MRI where you can put the women on and get the same images every time, only much faster and at a fraction of the cost of a breast MRI with images beyond that of a mammogram.

Local 4's Rhonda Walker put it to the test herself. She said to scan both breasts, it took less than five minutes.

Walker said the procedure is quick, very relaxing, with no squeezing or discomfort. She said one of the things she likes is the privacy, as she never felt the awkwardness of being full exposed.

The images are done for the radiologist to review in 15 minutes while the patient is still in the room.

Lisa Bey-Knight has been a research nurse coordinator for the clinical trial for seven years.

"This technology, I'm just blessed to be a part of it," said Bey-Knight. "This is pioneering technology."

Edmunds was diagnosed with breast cancer while pregnant with her daughter last spring. She has a healthy 5-month-old today and said she has quite a story to tell her.

"I could have lost my daughter at any time," said Edmunds. "I've had two ultrasounds, two mammograms, a mastectomy, chemo now. I'm going through radiation all during the nine months of pregnancy."

What Edmunds said she likes most about Softvue is the use of no radiation.

"When you deal with radiation, you deal with a lot. Effects your skin, your bones." said Edmunds. "(This) makes you feel comfortable that their doing the test and it's not harmful to your body. It uses water and uses sound and why we think it's potentially a good option in the future, because with mammography, it doesn't work that way."

It's important to remember mammograms are still the gold standard for breast cancer screening and detection. SoftVue clinical trials are ongoing.

SoftVue is just one example of the research taking place at the Karmanos Cancer Institute. One of the big events that helps fund that research is the "Karmanos 31st Annual Dinner," which will be held on Apr. 20th. General Motors is a major sponsor of the event.